Cleared Traditional

K253764 - ENOS Software Guided External Fixation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253764 · Disior, Ltd. · Orthopedic device
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Feb 2026
Decision
93d
Days
Class 2
Risk

K253764 is an FDA 510(k) clearance for the ENOS Software Guided External Fixation System. Classified as Software For Diagnosis/treatment (product code OSN), Class II - Special Controls.

Submitted by Disior, Ltd. (Helsinki Uusimaa, US). The FDA issued a Cleared decision on February 26, 2026 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Disior, Ltd. devices

Submission Details

510(k) Number K253764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2025
Decision Date February 26, 2026
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OSN Software For Diagnosis/treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Paragon 28, Inc.
Edward Wells-Spicer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.